CHK-ISO-001 Audit Readiness Checklist

Pre-Audit Checklist

• [x] Quality policy and quality objectives are current.
• [x] Controlled document list is complete and revision status verified.
• [x] Device 1 and Device 2 files are complete and available.
• [x] CAPA records include effectiveness verification.
• [x] Internal audit records and closure evidence are available.
• [x] Management review minutes are approved.
• [x] Risk management files include residual risk evaluation.
• [x] Training and competency records are complete.

Evidence Bundle

• Audit plan and checklist
• Document register export
• CAPA summary report
• Risk file summary per device
• Traceability matrix